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Open-label Study to Evaluate Metreleptin in Children Under 6 Years of Age With Generalised Lipodystrophy

RECRUITINGPhase 3Sponsored by Amryt Pharma
Actively Recruiting
PhasePhase 3
SponsorAmryt Pharma
Started2025-05-23
Est. completion2026-09-30
Eligibility
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06502990

Summary

This is an open-label, Phase 3b study to evaluate effectiveness, safety and pharmacokinetic parameters of metreleptin in patients under 6 years of age with generalised lipodystrophy and associated diabetes mellitus and/or hypertriglyceridaemia

Eligibility

Healthy volunteers accepted
Inclusion Criteria:

* Confirmed diagnosis of Generalised Lipodystrophy
* Metreleptin treatment naive

Exclusion Criteria:

* Weight \<9 kg at Screening (Visit 1)

Conditions2

DiabetesGeneralized Lipodystrophy

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